This website is dedicated to providing public information regarding DePuy Hip recall and other related information to the recall. None of the information on this site is intended to be formal legal or medical advice, nor should any information on this site be construed as advice that should be used in lieu of information from your attorney or physician.

Tuesday, December 4, 2012

comments from an MD invovled with Cobalt Related issues with his hip

I published this comment but thought it was worth seeing as a primary topic on the blog.

Hi Connie,
Since the Alaska Epi report
our first two cases have been detailed in the 12/2010 American JBJS. A more
general paper on identifying patients at risk for cobalt poisoning was publish
in Alaska Medicine in Summer 2010. These paper are easily found on line. We now
have about 25 patients that have required revision of metal-metal hips because
of Adverse Reactions to Metal Debris (ARMD), of those six likely have cobaltism.
There are now about 14 published case of arthroprosthetic cobaltism. So far the
toxic patients have had blood cobalt levels > 14 mcg/Liter. Early symptoms
can include mood changes and tinnitus (ringing in the ears), rashes, and being
easily winded. Patients with cobalt levels in excess of 20 mcg/Liter have been
noted to develop stiffening of the heart on echocardiogram and high frequency
deafness, and cognitive decline. Patient with blood cobalt level > 100 have
been reported to have developed deafness, blindness, overt heart failure,
hypothyroidism or goiter (enlargement of the thyroid gland), and peripheral
neuropathy (numbness and weakness in the
extremities).

Stephen Tower, M.D., was injured by the same artificial hip
he implanted in patients.Photo by:
Clark James Mishler

If any patient should have gone into a hip replacement
fully informed, it was Stephen Tower, M.D., 55, an orthopedic surgeon from
Anchorage, Alaska. Instead, he became the victim of another device that was
grandfathered onto the market without clinical testing.

In this case, it was an artificial hip introduced in 2005
by DePuy, the orthopedic division of Johnson & Johnson. Called the ASR XL
(shown at the top of this page), it was distinctive because both components—the
ball at the top of the femur and the socket liner inside the pelvis—were made of
chrome-cobalt metal.

The FDA cleared it without clinical testing based on
“substantial equivalence” to earlier devices, though such metal-on-metal hips
had long been on the agency’s high-priority list for requiring advance clinical
trials.

The all-metal hips were supposedly a great advance over
hips with the traditional plastic socket liner, Tower recalls. “The main reason
hips traditionally failed was because of plastic wear,” he says. “The
metal-on-metal hip was being promoted not only commercially but in the medical
literature as being a solution for patients like me, who wanted to return to
no-holds-barred physical activity.”

By 2006, Tower’s arthritic hip had forced him to give up
practically all the outdoor pursuits he had moved to Alaska to enjoy. He had a
DePuy ASR XL implanted in May of that year, and “within six weeks I did a double
century bike race,” he says. He was so enthusiastic that within 10 months he had
put various models of metal-on-metal hips in six of his
patients.

But by the time a year had passed, it became clear that
something was wrong. His hip was “pretty much constantly painful” and the
chromium and cobalt levels in his blood “were notably high,” he says.Then he
started noticing other problems, such as disturbed sleep, mood swings and
anxiety, hearing loss, visual problems, and tinnitus.

Tower’s symptoms became so severe at times that he was
unable to work. Meanwhile, his research, some of which he has since published in
medical journals, was uncovering evidence that metal debris from joint implants
can cause what he describes as “profound poisoning.”

After having the hip removed in 2009 and replaced with a
new one made of ceramic and plastic, his symptoms have markedly
improved.

In August of 2010, DePuy recalled all 93,000 ASR XL hips
worldwide after it became clear that the device was failing far more often than
average and producing serious injuries. While it’s unclear how many people
actually have had to have their artificial hip removed, an article in the
British Medical Journal called it “one of the biggest disasters in orthopaedic
history.”

Although the hip was invented and manufactured by an
American company, the recall occurred because as early as three years
previously—even as DePuy’s engineers were assuring Tower that the hip had no
problems—regulators in Australia, England, and Wales were noticing serious
problems.

They were able to do so because they have national joint
registries—a list of every joint implanted—and the ability to track how patients
fare with various models. There is no such national registry in the U.S.,
although Kaiser Permanente has a large private one.

The FDA has a voluntary system whereby doctors,
manufacturers, and patients can report problems with medical devices. And though
experts estimate that only a fraction of device problems ever get reported, from
2009 through 2011, the agency received 20,518 reports of injuries from
metal-on-metal total hip replacements. Of those, 15,137 concerned the now
recalled DePuy hip. Many of the remaining complaints concerned several other
brands and models that are still on the market in the U.S.

The 2011 Institute of Medicine panel concluded that the
FDA’s ability to spot problems is so inadequate that it’s “impossible to
confidently draw broad conclusions about the safety and effectiveness of
products that are on the market.”